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Completed

NCT Number: NCT06058884

Predictors of AIS Unfavorable Outcomes

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.

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Key information

Conditions

Ischemic Stroke Alteplase Adverse Reaction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

About this study

Investigators conducted a prospective cohort study between January 2022 and June 2023 and screened 1184 patients presented with AIS and received alteplase and included 592 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.

The investigators assessed mRS after 90 days via a 10-minute telephone interview. With patients or their primary caregivers to detect the score, all of our patients had baseline mRS of zero. mRS two or less was considered a favourable outcome

The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes, while the second group comprised 136 patients who experienced unfavourable outcomes.

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis.

Exclusion criteria

  • The investigators excluded patients who had not been followed up on for 90 days after enrollment,
  • Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded
  • The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).
  • The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings.
  • The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks.
  • The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest.

Treatment and study plan

alteplase

Drug

Following the guidelines set forth by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit.

Primary outcomes

  1. modified Rankin scale (mRS)

    Time frame: 90 days

    To detect the score, investigators assessed modified rankin scale (mRS) after 90 days via a 10-minute telephone interview with patients or their primary caregivers. mRS two or less was considered a favourable outcome.

    mRS is a scale that assessed the outcome of stroke patients and its score ranged from zero to six. the lower the values the better the outcome

  2. predictors of the unfavourable outcomes

    Time frame: 90 days

    The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict the unfavourable outcomes after 90 days of acute ischemic stroke.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Predictors of the Unfavourable Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase, a Multi-centre Prospective Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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